Trial Outcomes & Findings for IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients (NCT NCT03553498)
NCT ID: NCT03553498
Last Updated: 2022-03-02
Results Overview
The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
162 participants
Primary outcome timeframe
Before treatment to 60 minutes after treatment
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
IV Hydromorphone and IV Acetaminophen
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
IV Hydromorphone and IV Acetaminophen
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Overall Study
Missing primary outcome
|
1
|
2
|
Baseline Characteristics
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
Baseline characteristics by cohort
| Measure |
IV Hydromorphone and IV Acetaminophen
n=80 Participants
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=79 Participants
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic/Latino
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · African-American
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
79 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Location of Pain
Abdomen/flank
|
70 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Location of Pain
Other
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Pain Intensity on Numerical Rating Scale
6-7
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Pain Intensity on Numerical Rating Scale
8
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Pain Intensity on Numerical Rating Scale
9
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Pain Intensity on Numerical Rating Scale
10
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Nauseated or vomited in Emergency Department before treatment
Yes - nauseated or vomited
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Nauseated or vomited in Emergency Department before treatment
No - not nauseated, did not vomit
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before treatment to 60 minutes after treatmentThe between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment
Outcome measures
| Measure |
IV Hydromorphone and IV Acetaminophen
n=80 Participants
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=79 Participants
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
|
6.2 units on a scale
Interval 5.6 to 6.8
|
5.4 units on a scale
Interval 4.7 to 6.1
|
SECONDARY outcome
Timeframe: Baseline to 60 minutes post-baselinePopulation: All patients in the study
Difference in percentage of patients who received additional pain medication within 60 minutes of administration of study medication in the two arms of the study
Outcome measures
| Measure |
IV Hydromorphone and IV Acetaminophen
n=80 Participants
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=79 Participants
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 61 to 120 minutes post-baselinePopulation: All patients in study
Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group
Outcome measures
| Measure |
IV Hydromorphone and IV Acetaminophen
n=80 Participants
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=79 Participants
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Immediately after administration of study medication to 120 minutes after administration of study medicationPopulation: Patients who were still in Emergency Department 120 minutes after medication was administered
Number of patients who answer "yes" to question: "Do you want more pain medication" divided by number of patients
Outcome measures
| Measure |
IV Hydromorphone and IV Acetaminophen
n=78 Participants
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=77 Participants
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
Percentage of Patients Who Want Additional Analgesics
|
21 Participants
|
29 Participants
|
Adverse Events
IV Hydromorphone and IV Acetaminophen
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
IV Hydromorphone and Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Hydromorphone and IV Acetaminophen
n=80 participants at risk
1000 mg IV acetaminophen administered over 5-10 minutes
IV acetaminophen: acetaminophen given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
IV Hydromorphone and Placebo
n=79 participants at risk
100 ml IV normal saline administered over 5-10 minutes
IV placebo: given intravenously
1 mg hydromorphone: hydromorphone given intravenously
|
|---|---|---|
|
General disorders
Oxygen Desaturation
|
3.8%
3/80 • Number of events 3 • During the entire study - within 2 hours after administration of study medication
|
1.3%
1/79 • Number of events 1 • During the entire study - within 2 hours after administration of study medication
|
|
General disorders
Hypotension
|
1.2%
1/80 • Number of events 1 • During the entire study - within 2 hours after administration of study medication
|
1.3%
1/79 • Number of events 1 • During the entire study - within 2 hours after administration of study medication
|
|
General disorders
Bradycardia
|
0.00%
0/80 • During the entire study - within 2 hours after administration of study medication
|
1.3%
1/79 • Number of events 1 • During the entire study - within 2 hours after administration of study medication
|
|
General disorders
Nausea and/or Vomiting
|
7.5%
6/80 • Number of events 6 • During the entire study - within 2 hours after administration of study medication
|
10.1%
8/79 • Number of events 8 • During the entire study - within 2 hours after administration of study medication
|
|
General disorders
Pruritis
|
13.8%
11/80 • Number of events 11 • During the entire study - within 2 hours after administration of study medication
|
15.2%
12/79 • Number of events 12 • During the entire study - within 2 hours after administration of study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place